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Pooled Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing viral load of SARS-CoV-2 To evaluate the clinical efficacy of REGN10933+REGN10987 compared to placebo, as measured by death or mechanical ventilation Phase 1/2 (Cohort 1) To exclude futility of REGN10933+REGN10987 compared to placebo, as measured by death or mechanical ventilation To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo
A study to research the experimental drugs REGN10933 and REGN10987, given together as a treatment for people with COVID-19. The study is focused on people who have COVID-19 but do not need to be in the hospital.
To compare the efficacy of nirmatrelvir (PF-07321332)/ritonavir to placebo for the treatment of symptomatic COVID-19 in non- hospitalized pediatric participants with COVID-19 who are at risk of progression to severe disease. Patients are randomized 1:1 and will receive placebo or the investigational product orally for 5 days. Patients will complete in-person and remote follow-up visits including assessments such as nasopharyngeal swabs, blood draws, and physical exams.
This research study is looking at experimental drugs to prevent the COVID-19 disease from occurring in people who have been exposed to the SARS-CoV-2 virus. The goals of the study is to see if REGN10933+REGN10987 lowers infection by the virus, whether they reduce the need for medical visits and the amount of time spent away from your day-to-day activities (i.e., work, school, caring for others) due to COVID-19, and whether they can cause side effects.
The primary hypothesis to be tested is whether or not there is a difference in time to sustained alleviation of all targeted COVID-19 signs and symptoms through Day 28 between PF-07321332/ritonavir and placebo.